Dicopanol recall: Sterility Concern
DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) FusePaq, 150 mL Kits, Rx Only. Fusion Pharmaceuticals LLC., 768 Calle Plano…
Why was Dicopanol recalled?
Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: PL713, PL714, PL715, PL716, PL717, PL718, PL719, PL720, PL721, PL722, PL735, PL736, PL737, PL738, PL739, PL740, PL741, PL742, PL743, PL744; Expiry: 7/20/2015.
- Product
- DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) FusePaq, 150 mL Kits, Rx Only. Fusion Pharmaceuticals LLC., 768 Calle Plano…
- Recalling firm
- Fusion Pharmaceuticals, LLC
- Quantity
- 9,439 Kits
- Distribution
- California
- Recall date
- March 18, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)